Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11

NCT04591405 | Unknown Phase 2 DMC

• 1 other identifier: 20190710
• Study Type: interventional
• Target: 11,999
• Locations: 1 country
• Sites: 1

Brief Summary

Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland suppurative swelling and pain with fever. The pathological changes and harm caused by mumps was not only confined to the parotid gland, on the contrary, the social harm caused by serious complications cannot be ignored. As mumps is a vaccine-preventable infectious disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13 genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain of MuV in China was the F genotype. The commonly used vaccine strains represented only a small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A strain, which was the first separation and preparation of the attenuated mumps viruses in China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much safer to use. The results of phase I and II clinical trials showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity in infants (8-24 months old).

Conditions

Epidemic Parotitis, Mumps

Keywords

Mumps; F-genotype; Live Attenuated Vaccine; Human Diploid Cell

Outcome Measures

Primary Outcomes (3)

• Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine

  To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.

  28 day after the vaccination

• Phase II: Positive conversion rate of MuV neutralization antibody of MuV Vaccine

  To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.

  28 day after the vaccination

• Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps according with the protocol

  To compared the the number of cases of mumps in the vaccine group and the placebo group after 29-day-post injection within 12 months after vaccination

  within 12 months after vaccination

Secondary Outcomes (11)

• Phase II/III: Adverse reactions/events rate

  within 14 days after vaccination

• Phase II/III: Adverse reactions/events rate

  within 28 days after vaccination

• Phase II/III: Serious adverse events rate

  within 12 months after vaccination

• Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody

  28 day after the vaccination

• Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody

  28 day after the vaccination

Study Arms (4)

Attenuated Mumps vaccine (KMB-17) in phase II and III

EXPERIMENTAL

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 360 children (5-11 years old) on 0 day

Biological: Attenuated Mumps vaccine (KMB-17) in phase II and III

Placebo in phase II

PLACEBO COMPARATOR

Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day

Biological: Placebo in phase II

Attenuated Mumps vaccine (KMB-17) in phase III

EXPERIMENTAL

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 5640 children (5-11 years old) on 0 day

Biological: Attenuated Mumps vaccine (KMB-17) in phase III

Placebo in phase III

PLACEBO COMPARATOR

Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day

Biological: Placebo in phase III

Interventions

Attenuated Mumps vaccine (KMB-17) in phase II and III BIOLOGICAL

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 360 children (5-11 years old) on 0 day

Attenuated Mumps vaccine (KMB-17) in phase II and III

Placebo in phase II BIOLOGICAL

Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day

Placebo in phase II

Attenuated Mumps vaccine (KMB-17) in phase III BIOLOGICAL

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 5640 children (5-11 years old) on 0 day

Attenuated Mumps vaccine (KMB-17) in phase III

Placebo in phase III BIOLOGICAL

Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day

Placebo in phase III

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy people aged 5-11 years (including boundary values), both men and women.
• Proven legal identity.
• Participants and parent(s)/legal guardian(s) should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
• Participants and parent(s)/legal guardian(s) should be able to communicate well with investigators, understand and comply with the requirements of this trial.
• Axillary temperature ≤37.0 ℃.

You may not qualify if:

• Contraindications for vaccination.
• History of allergy to vaccines or drugs
• Have a history of mumps disease
• Except for one dose of vaccine containing mumps at the age of 18\~24 months before enrollment, any vaccine containing mumps has been vaccinated.
• Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
• Convulsant,encephalopathy,psychosis or family history of epileptics.
• Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
• For any reason, the spleen was removed partially or completely
• Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will cause the contraindication of subcutaneous injection
• Suffering from congenital deformity or serious chronic disease(congenital heart disease，Down's syndrome,diabetes,sickle cell anemia,nervous illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
• Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant, cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis or corticosteroids to cure noncomplication acute dermatitis ).
• Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
• Any prior administration of other research medicines during the same period.
• Any other situations judged by investigators as not suitable for participating in this study

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Hubei Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Mumps

Interventions

Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic

Condition Hierarchy (Ancestors)

Rubulavirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Qihan Li

  Institute of Medical Biology, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled design

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 19, 2020
• Study Start: October 12, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CN (1)